Catalog Number

-

Brand Name

Mehta Laryngeal Stent

Version/Model Number

MLS-12-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K841347

Product Code

FWN

Product Code Name

Prosthesis, Larynx (Stents And Keels)

Public Device Record Key

5fad7e30-8303-431e-9f17-17eaae33a55b

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

April 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-